Automated, selectable, soft tissue excision biopsy devices and methods

ABSTRACT

An excisional biopsy and delivery device may comprise one or more rotating, penetrating and cutting rod elements. The rod elements may be configured to advance from a stored and confined first position and rotate about an axis, while being simultaneously revolved about a central axis. The rod elements may then assume a second released and expanded configuration that is operative to cut around and surround target tissue. In this manner, the rod elements are operative to move through the surrounding tissue to create a volume of revolution and to sever and capture the target tissue contained within the volume of revolution from the surrounding tissue. The severed and captured volume of revolution containing the target issue may then be removed.

BACKGROUND

Embodiments are in the technical field of medical devices and methods.More particularly, embodiments are in the technical field of imageguided soft tissue surgical diagnostic and therapeutic procedures,including devices for capture, immobilization, isolation, excision andretrieval of any tissue that is surrounded by soft tissue or foreignbodies surrounded by soft tissue, and corresponding methods forcapturing, immobilizing, isolating, excision of, and retrieving anytissue or foreign bodies surrounded by soft tissue.

SUMMARY

Embodiments are drawn to various medical and surgical devices andmethods that may be used for excision procedures, including the capture,immobilization, isolation, excision (resection) and retrieval ofnormal-appearing and/or abnormal-appearing tissues surrounded by softtissue or foreign bodies surrounded by soft tissue. Embodiments alsoinclude devices and methods for intra-procedure or subsequent shaping ofthe cavity from which the target tissue or foreign body is excised,thereby enabling optimal subsequent post-procedure methods. Embodimentsmay also be configured to capture, immobilize, isolate and providetreatment or materials to tissues or foreign bodies without subsequentexcision or retrieval, if desired. Embodiments may also comprisestructures and functionality for the different phases of the surgicalprocedure, which may comprise stopping, repositioning and re-startingthe procedure in a minimally invasive fashion. Embodiments may be usedin single insertion-single retrieval, single insertion-single isolation,or single insertion-multiple isolation modes. Embodiments may beconfigured to be portable, disposable, recyclable or reusable and may beelectrically, mechanically and/or manually powered and operated.

Embodiments may also comprise or enable:

-   -   the capability for pre-procedure treatment of an area and/or of        a tissue or foreign body:    -   the delivery of tracer materials for tracking the potential        spread or flow patterns whereby tissues (such as cancerous        tissues) may metastasize;    -   the pre-procedure or intra-procedure delivery of medications        that may anesthetize tissues on the way to, at the site or upon        leaving the site, or other therapeutic agents such as        pro-coagulants and others;    -   the delivery of intra-procedure or post-procedure materials,        including but not limited to medications, implantable materials        for cosmetic or therapeutic purposes (including but not limited        to brachytherapy sources or transplant tissue or cells), and        other implantable elements such as marking devices for later        imaging reference; and    -   the provision of a direct path to the site for a removable fiber        optic cable to deliver light energy or enable visual inspection        of the site.

Embodiments may also comprise capabilities for other techniques such asover the wire (Needle Loc) or percutaneous locating tube entry methodsto approach a target tissue or foreign body. Embodiments may alsocomprise the use of vacuum-assisted collection and retrieval methods to,among other purposes, aid in the control of movement of tissues(including but not limited to cells and fluids) and other materials fromthe target site to a site external to the body, or to provide suchmaterials for analysis or any other procedures, including transplant.Embodiments may also comprise the use of radiofrequency (RF) energypowered cutting elements and structures. Embodiments, along withassociated related subcomponents described herein, may be configured toprovide the capabilities, in automatic or semi-automatic modes, tocapture, immobilize, isolate, excise and retrieve solid, contiguousand/or fragmented tissues, foreign bodies and other materials as well asliquid and semi-solid tissues as well as the delivery of gasses,liquids, semi-liquids or solids to the site post-procedure. Such may becarried out for, among other reasons: histopathology, polymerase chainreaction, or any other analytical procedures; diagnosis; treatment;transplant; cosmetic procedures; or any other desired procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a device according to one embodiment, and shows differentphases of deployment thereof;

FIG. 2A and FIG. 2B shows two perspectives of the spatial travel of atip of a rod element deployed from a tube chamber, according to oneembodiment. FIG. 2 a is a top down view of a tip's path and FIG. 2 b isa side view of a same tip path as it leaves a mouth of a tube chamber;

FIG. 3A, FIG. 3B, FIG. 3C and FIG. 3D illustrate several embodiments ofa sphere or near spherical shape that may be configured to becircumscribed by a tip of a single rod element, following a path shownin FIG. 1 and FIG. 2A and FIG. 2B, and assuming that a tube chamber isalso rotated at the same time. FIG. 3 a is a top down view of a path ofa tip of a curved tip, according to one embodiment. FIG. 3 b is a sideview of a path of a tip of a curved tip, according to one embodiment.FIG. 3 c is a side view of a curved tip of a rod element as it would bein its final shape and position relative to a theoretical sphere itcircumscribes after having completed its penetration/rotational travelfrom a mouth of a tube chamber, according to one embodiment. FIG. 3Dshows representative spiraling grooves.

FIG. 4 a, FIG. 4 b, FIG. 4 c. FIG. 4 d, FIG. 4 e and FIG. 4 f are sideviews of a number of rod element curved tip shapes according toembodiments, including different sizes, different appendages that areconfigured to expand laterally as a tip element curves into its naturalshape upon leaving a tube chamber, and different cutting edgevariations, according to embodiments. Also illustrated in FIG. 4 g. FIG.4 hl FIG. 4 i and FIG. j are cross-section of various shapes of a curvedtip element 5, according to embodiments. Lastly, FIG. 4 k, FIG. 4 l andFIG. 4 m show a locating wire (typically abbreviated “Needle Loc”) foroptional use with a device, according to embodiments.

FIG. 5 shows three views of a continuum of motion, from top to bottom,in the deployment of a rod element from a tube chamber, according to oneembodiment.

FIG. 6 is an end-on view of a distal end of an outer tube/penetrationbarrel, having placed within it a number of tube chambers, whichthemselves surround a central tube which may, in turn, be centeredspatially within its own tube sleeve and/or over a locating wire,according to one embodiment.

FIG. 7A, FIG. 7B, FIG. 7C and FIG. 7D show different side views of adistal end of one embodiment in various modes, according to oneembodiment.

FIG. 8 is an external side view of one embodiment of the device of FIG.1, illustrating various controls, indicators and features, according toone embodiment.

FIG. 9 is a top view of one embodiment of the device of FIG. 1, as shownin FIG. 8, according to one embodiment.

FIG. 10 is a side view of another configuration and embodiment of thedevice of FIG. 1, according to one embodiment.

FIG. 11 is a side view of the device of FIG. 10, according to oneembodiment.

FIG. 12 is a top view of the device 10 according to one embodiment.

FIG. 13 is a side view of the device of FIG. 10, according to oneembodiment.

FIG. 14 is a side view of the device 1 of FIG. 10, according to oneembodiment.

FIG. 15 is a top down view of an upper level of the device 1 of FIGS. 8and 10, according to one embodiment.

FIG. 16 is a top down view of the transfer case and driving mechanismwithin the upper unit of the device of FIGS. 8 and 10, according to oneembodiment.

FIG. 17 illustrates three perspective views of one portion of a deviceof FIGS. 8 and 10, according to one embodiment.

FIG. 18 shows the device of FIG. 8 illustrated to approximate relativescale, in one embodiment, with added external button lock element aswell as external carriage position indicator, according to oneembodiment.

DETAILED DESCRIPTION

Reference will now be made in detail to the construction and operationof embodiments illustrated in the accompanying drawings. The followingdescription is only exemplary of the embodiments described and shownherein.

Biopsy and other surgical procedures are used to remove tissues forhistopathology analysis or for therapeutic reasons in many areas of thebody. Techniques for these procedures have evolved over time, fromsimple open surgical biopsy as a traditional procedure to the use ofadvanced biopsy devices that are designed to provide a less invasive orminimally invasive alternative to traditional open surgical biopsy. Thechallenges for all such procedures and devices are to be able toapproach a target tissue that is a candidate for biopsy or completeexcision with minimal disturbance to sensitive surrounding tissue on theway to or in proximity to a target tissue; to effectively surround atarget tissue without disturbing it in order to capture, immobilize(where this is necessary), isolate and excise a target tissue; to ensureclear margins of healthy tissue around a target tissue in the event thatthe procedure is a lumpectomy and to provide for effectivepost-procedure follow-on treatment of the cavity as determinednecessary. Embodiments are designed to meet all of these challenges,including capabilities to isolate a target tissue or foreign body and,where desired, a clear margin of healthy tissue from the surroundingarea while avoiding sensitive tissues and body structures on the way toand in the vicinity of a target, thereby minimizing damage such assevering, puncturing through, contaminating, etc., to surroundingstructures, such as blood vessels, nerves, lymph nodes, adjacent organs,chest wall, and others; and then to remove a target from the body foranalysis or any other procedures, and subsequent therapeutic treatmentof the resulting cavity; accomplishing all of this with minimalinvasion/tissue damage during the entire process, not simply on entryinto the body.

Embodiments enable a complete removal of target tissues or foreignbodies in a single percutaneous entry pass, while at the same timeleaving behind an optimized spherical or other three dimensionallyshaped cavity for further treatment methods, some of which are extremelydependent for their effectiveness, reaction timing and avoidance ofcollateral damage to nearby tissues on as spherical a cavity as ispossible to achieve. Such post-procedure treatment (radiation therapy,drug eluting implant therapy, and others where it is desired touniformly treat the tissue on the walls of the cavity but not beyond it,or with too much treatment adjacent to one cavity wall while noteffectively or efficiently reaching the other side of the cavity) hasbeen shown to be most effective under such conditions. Embodiments maybe configured to enable effective core sampling for analysis biopsyprocedures as a follow-on procedure (where a targeted tissue site isknown or suspected to be carcinogenic, for instance) to completelyremove a target tissue with clean margins of healthy tissue as soon aspracticable, using the same entryway created by core sampling biopsydevices, and to leave behind an optimized spherical or nearly sphericalor other optimally shaped cavity from whence the suspect tissue wastaken. In addition or alternatively, the embodiments may be used as apreventive measure, either through complete removal of a target tissueor foreign body using these embodiments or by alternate means, such asmanual surgical removal of the target tissue following tissue isolationusing these embodiments or through simple isolation of a target tissueor foreign body for subsequent clearance by the body's immune system orinjected substances.

Use of embodiments to isolate a tissue or foreign body withoutsubsequent removal from the body (at least immediately) may accomplishseveral important surgical and therapeutic goals, including cutting offthe blood supply to a tissue, preventing invasion of a tissue intosurrounding tissues, or simply allowing the body's immune system achance to attack and clear a tissue or foreign body from all sides oncethe target has been weakened by isolation. When one or more of theseobjectives has been accomplished, a target may begin to diminish in sizeand/or viability over time, providing the opportunity to periodicallyre-evaluate the target with various imaging and other diagnostictechniques (such as ultrasound, CAT-scan, PET-scan) and allowing thephysician to design follow-up treatment(s) (radiation, chemotherapy,subsequent open surgical excision, and/or any other treatment optionsapplicable) at the most optimum rate and schedule and as the patient isable to tolerate treatment. Embodiments have the advantage of enabling achoice to decrease the dose or change the type of the treatment(s)required, particularly if the target diminishes over time, in order tominimize toxicity and other undesirable side effects of suchtreatment(s). Simple isolation of a target with minimally invasiveprocedures as enabled by embodiments and without (at least immediate)subsequent removal from the body may in fact be necessary in some cases.Such cases may include, for example, situations when a patient issignificantly compromised and/or in a decompensated state and not ableto tolerate the target removal procedure; when a target is in a verysensitive area that may not allow for withdrawal of the target through apercutaneous approach site; when the target contains toxic material, forexample, an encapsulated abscess; when the target is friable andtherefore not a desirable candidate for removal (at least immediatelyafter isolation); or any other situation where removal of the target (atleast immediately after isolation) is not advisable or possible.

FIG. 1 shows several illustrations of a device 1 according to oneembodiment. As shown, the device 1 may comprise a rod element 2comprising a curved tip portion, loaded inside a non or differentiallyrotating tube chamber 3, and actuated by a rod actuator 4 (including,but not limited to, being disk shaped or simple crank, cam, or othergear system). The rod actuator 4 may be configured to engage theproximal end of a rod element 2. The vertical line passing through allfive of the illustrations of the device 1 represents an exemplarypercutaneous entry point into the body to show relative positioning ofthe elements of the device in use. The illustrations, from top tobottom, show various phases or positions, including:

-   -   (a) at-rest (loaded) position;    -   (b) initial penetration/start of rotation/start of a curved tip        5 extension position;    -   (c) continued penetration/continued rotation position;    -   (d) half-way penetration/half-way (approximately 90 degrees of        rod rotation from rest position within the tube chamber)        rotation position, and    -   (e) fully deployed (approximately 180 degrees from rest        position), which denotes the end of both forward penetration        (axial extension from) and rotation of a rod element 2 within a        tube chamber 3, as well as showing that a curved tip 5 of a rod        element 2 has achieved its natural shape, as opposed to its        relatively flattened shape within the tube, as seen in the top        illustration.

Such action may also be accompanied (not illustrated) by rotation of atube chamber 3 during forward penetration/rotation movement of a rodelement 2. FIG. 1 shows the relative positioning of a rod element 2 witha non- or differentially rotating tube chamber 3 at various phases ofdeployment. The curved tips of a rod element 2 may be configured to beflexible, and may be flat or nearly flat when initially loaded into atube chamber 3 (position (a)), to thereafter gradually assume theirnatural fully-deployed shape (half circle or other desired shape), asshown in position (e), having rotated on a rod element axisapproximately 180 degrees, in this instance, from their initial positionin a tube chamber 3. To enable such tip action to occur, the rod elementmay be constructed of springy material, such as metal alloy, carbonfiber, or a shape-memory material such as, for example, Nitinol®, aNickel-Titanium alloy. It is this combination of axial movement, coupledwith rotation of a rod element with its curved tip, and coupled withspatial revolution of the tip and sides of a curved tip along with othermotions that enables the functionality of the embodiment.

The rod element 2 may be loaded into a tube chamber 3 with a curved tip5 flattened inside the tube chamber to enable the device to have assmall an initial tip cross-section as possible which, in turn, allowsfor percutaneous insertion into the body (minimally invasive) andcontinued minimal invasion as the tip of the device 1 advances toward atarget tissue or foreign body site, either following the path of aprevious device and procedure, or in making its own path to a targetsite. Only when in proximity to a target site is it desirable to deploythe curved tip 5 from the tube chamber 3 around a target tissue withoutpenetrating such target tissue, and even then, the path of a tip ofcurved tip 5 may describe a minimally invasive pattern, which may resultin final positioning of a curved tip before rotation to carve out aspherical or near spherical shape to isolate a target tissue, lesion orforeign body from surrounding healthy tissue without disturbing such atarget. In this manner, a sphere or near spherical shape may beisolated, which shape is, by definition, the least invasivethree-dimensional shape that can contain a target tissue of a given sizeand diameter, unless a target is unusually and atypically shaped. Forinstance, if the target tissue is very long compared to its diameter, adifferent curved tip shape may be selected to accommodate such a targettissue. The tube chamber 3 may also serve as a delivery tube formedications and other materials. The tube chamber 3 may also beconnected at its proximal end (to the right on the drawing) to a vacuumapparatus for collection of fluids, cells and other materials from atarget site for disposal, for later histopathology analysis or any otherdesired procedures.

According to one embodiment, rod element 2 may be hollow with aperturesalong the curved tip 5 to elute anesthetics, other medications, or othermaterials intra-procedure, and may be coupled to a radiofrequency (RF)energy source at its proximal end, if desired, to enhance its tippenetration/side cutting efficiency. In that case, the tube chamber 3may be provided with an inner surface treatment having insulatingcharacteristics, or alternatively, the tube chamber 3 may comprise anon-conductive and RF energy resistant material. The base end of theshaft of the rod element 2 may be configured to positively engage andlock into rod actuator 4, specifically for the purpose of controlling,with the tube chamber, the rod's penetration and withdrawal from atarget site and the body.

FIGS. 2A and 2B show two perspectives of the spatial travel of the tipof a rod element 2, according to one embodiment. FIG. 2A is an end on(polar view) illustration of the three-dimensional path taken in spaceby the very tip of the curved tip of rod element 2 as it penetratesforward (up out of the plane of the illustration) while rotatingoptimally approximately 180 degrees from its initial rest positionwithin tube chamber 3. This illustrates that the overall shape of andassumed by, the curved tip as it is released from its chamber tube. Therelative speed of rotation and the speed of penetration, if preciselycoordinated, act in concert to cause the tip to describe athree-dimensional path, similar to that of drawing a spiral line on theoutside of a sphere, and that a tip, after having rotated at least 180degrees from its initial pointing position, will arrive at the top poleof the sphere without having disturbed any point within the sphere. Oneembodiment comprises circumscribing an additional path in space of thesides and tip of a curved tip 5 of rod element 2 if the tube chamber 3is also rotated synchronously with the rotation/penetration movement ofrod element 2. FIG. 2B is a side view of the same tip path as it leavesthe mouth of a tube chamber 3, (which may be non- or differentiallyrotating), penetrates up and around a theoretical spherical shape inspace, from its initial position at the bottom (proximal pole of thesphere) to its final position (top or distal end of the sphere shape),according to one embodiment. The circumference of the sphere itselfdescribes the path the side of the curved tip 5 would carve sphericallywhen rotation continues following full tip deployment.

FIG. 3 show several illustrations of the action of a curved tip 5 undercombined axial/rotational/revolution movement, according to oneembodiment. FIG. 3A is a top down view of the path of the tip of acurved tip 5, according to one embodiment. FIG. 3B is a side view of thepath of the tip of a curved tip 5, according to one embodiment, assumingthat a tube chamber 3 is simultaneously rotated with rotation of a rodelement 2 within it, as rod element 2 travels axially forward (up in aside view). FIG. 3C is a side view of curved tip 5 of a rod element 2,according to one embodiment, as it would be in its final shape andposition relative to the theoretical spheroid or surface of revolutionit may have circumscribed after have completed itspenetration/rotational/revolution travel from the mouth of tube chamber3. If, having reached this position, rod element 2, with or withoutsimultaneous rotation of a tube chamber 3, was rotated about its own orcommon axis, the sharpened edges of a curved tip 5 may carve out asphere-like shape, isolating it as a ball or sphere from the surroundingtissue and containing a targeted tissue or foreign body 6 in its center.Many factors may influence the perfection of the spherical shape thatcan theoretically be carved by the complex motion combination of axialpenetration, rotation and complex (multiple) revolution, including acurved tip shape, resistance to bending or flexing, relative speeds ofthe motions involved, tissue density and uniformity of matrix, etc. Theresulting three-dimensional shape carved out, according to oneembodiment, may resemble that of a typical onion dome foundarchitecturally on Eastern European monuments as sketched in FIG. 3D.The spiraling grooves that are shown in FIG. 3D may be consideredrepresentative of the paths taken by curved tips 5 of multiple rodelements 2. If desired, once a target tissue or foreign body has beenremoved, a second pass with the same instrument in a configuration inwhich the tips thereof are fully deployed may be carried out, rotatingwithin the cavity to shave off additional tissue from the walls of thecavity remaining after the target tissue or foreign body has beenremoved. According to other embodiments, a different tip may besubstituted, with vacuum, to shave the outer walls of the cavity andretrieve tissues including, for example, cells and fluids, foreignbodies, and other materials down a central tube.

It is well-documented that the fewer disturbances there are to thesurrounding tissue in the area of a target tissue during an excisionprocedure, the better the recovery from the procedure with respect topost-procedure effects such as bleeding, nerve damage, and otheradjacent structural damage. Also improved are speed of healing; overallpatient well-being in terms of post-procedure pain, immune systemresponse, potential inflammation and other complications; and in somecases, the cosmetic result. Advantageously, embodiments enable a theunique action and spatial orientation of deployment of the distal end ofthe device to surround a target tissue, or foreign body surrounded bysoft tissue, to capture, immobilize, isolate from all surroundinghealthy soft tissue structures, and withdraw it from the body, may allbe conducted in a minimally-invasive manner, with little or no damage tosurrounding body structures. Indeed, embodiments feature axial movementof the tips of individual rod penetration elements from tube chamber(s),with simple rotation and forward (axial) movement coupled with complexrevolution of those same elements.

According to one embodiment, the rod elements may be configured torotate upon their own axes, and circumscribe a predetermined path whilethe device itself revolves. According to one embodiment, the rodelements may also be configured to travel axially as well, giving themtheir own spiral orbit path until they are fully deployed at the NorthPole of the spheroid collectively circumscribed by the advancing androtating rod elements. Significantly, according to one embodiment, thereis no violation of the center of the target tissue within the tissuespheroid that the rod and tip elements circumscribe, as the device doesnot penetrate the target tissue. This is made possible because the rodand tip elements, as they emerge from the base axis of the device, maybe configured to complete their course of movement without the need fora central supporting pole or being joined at their tips. Indeed,embodiments enable the excision and isolation of target tissue withoutthe need for any central penetrating structure, as described in detailbelow. Advantageously, pathologic analysis of the isolated/retrievedtissue specimen is not hindered by any alteration of the tissue itselfwithin the spheroid. According to one embodiment, the device thus keepsthe tissue specimen as close to its in-situ form and architecture aspossible.

In one embodiment, a thin guiding wire may be used as a guiding elementto the target. Such guiding wires, however, are slight in cross-sectionand may be left within the retrieved specimen when it is delivered forhistopathological examination. The guiding wire within the target mayalso function as a reference landmark. One embodiment, therefore, may beconfigured to combine, coordinate, and incorporate axial motion, simplerotation and complex revolution movements of its various components inorder to deploy, from a minimal initial tip cross-section, a structurethat may be configured to surround, capture, immobilize, isolate, exciseand/or retrieve a target tissue, or foreign body surrounded by normaltissue. Embodiments also may be configured to collect other materialsfrom a target site and deliver still other materials to a target site.

FIGS. 4 a through 4 m show several embodiments of the curved tip 5,showing different shapes, cross-sections, and locating wire shapes(referred to as a “Needle Loc” and used to mark a location of a suspecttissue within the body pre- or intra-procedurally). FIG. 4 a showsseveral standard dimensions (not to scale) that may be envisioned forthe curved tips 5 for use with different size target tissues to beisolated or excised, as well as for subsequent cavity shaping, accordingto embodiments. One embodiment of such curved tips may comprise a tipextremity extending over center and may also comprise a proximal spurwhere a curved tip 5 extends from a rod element 2, all of which may aidcomplete part-off of a tissue that may be surrounding tissue or aforeign body to be isolated or excised with at least one full rotationof a rod element 2 or revolution of a rod element 2 within a tubechamber 3. The tip extremities extending over center may serve to lockwith other curved tips at the end of their full deployment. FIG. 4 bshows another embodiment of a curved tip 5 comprising barbs that may beconfigured to deploy laterally upon release from a tube chamber 3,according to one embodiment. Such barbs may serve multiple purposes,including stabilizing a tissue or foreign body after it is carved out inthree dimensions, increasing the surface area of a curved tip 5 for abetter grip on a target to be isolated with excision, and maintainingthat grip on a tissue to be excised when withdrawing it through arelatively narrow entry pathway.

FIG. 4 c illustrates another embodiment comprising a curved tip 5 thatis not only curved, but partially spiraled in form as its natural shape.Such a shape may describe a more perfect theoretical sphere from sometypes of tissue. Additionally, this illustration shows an embodiment ofa tip configuration that is bent up at its extremity, which may enableit to ride over the surface of the sphere to be carved out, as opposedto digging into the sphere. FIG. 4 d illustrates yet another curved tip5 embodiment where a curved tip may comprise one or more elements thatare joined at the distal and proximal ends, or may be leaf-shaped. Thismay increase the surface area of a curved tip 5 in relation to thespheroid surface of a tissue or foreign body to be isolated or excised.FIG. 4 e shows a curved tip 5 in non-spherical natural state, accordingto one embodiment, which may result in a different three dimensionalform (other than a spherical shape) if such is the goal, as where aspherical shape might too closely approach an adjoining body structure,such as an organ or chest wall, and it is still desired to extract anefficiently shaped target specimen, leaving behind a reasonably shapedcavity for post-operative therapeutic measures or where a target tissuehas an elongated shape, for example. FIG. 4 f shows one possibletreatment for sharpened edges of a curved tip 5 which, according to oneembodiment, may be serrated as shown with tip interlockingcharacteristics upon full deployment, with eluting holes betweenserrations (not shown), or any other effective configuration, includingrelatively blunt edges if radiofrequency (RF) energy is to be used as acutting mechanism enhancement for a curved tip as it rotates for tissueseparation.

FIGS. 4 g through 4 j illustrate various possible cross-sections for acurved tip 5 according to embodiments, which may vary from one toanother along the chord of a curved tip 5. FIG. 4 j shows a so-calledtanto point, which is effective in penetrating distally and partingdense tissue and materials laterally. This point also has the advantageof being single edged, which is one possible cross-sectionconfiguration. This point also has the advantage that with a leadingsharp edge for forward penetration/rotation, it also has a bluntopposite edge, which may limit tissue damage if curved tips were to bewithdrawn back along their retraction/rotation pathway. Lastly, thisparticular cross-section 4 j may be used with or without RF energy veryefficiently, since it would have both a sharp edge for non-RF use and arelatively blunt edge, which may function to diffuse the RF energy alongthe edge for forward cutting from such a surface. Any of thecross-section shapes may also aid, with a slightly raised spine (FIG. 4g) in aiding tissue penetration under rotation, increasing stiffness ofa curved tip 5 in desired areas along the curve, or other purposes.Finally. FIGS. 4 k. 4 l and 4 m illustrate three embodiments of locatingwires and tips, which may be used as one component of this device. FIG.4 k shows such a locating wire 8 with a fixed pointed cap, which may beuseful in assisting a curved tip part-off at one phase of the procedure.FIG. 4 l shows such a locating wire 8 with a hinged barb tip, which maybe used to penetrate a target tissue or foreign body completely, andthen to be withdrawn at the end of the procedure with the rest of thedevice and target sample for direct correlation between what wasoriginally imaged for targeting and what was actually excised, whilealso aiding in maintaining the specimen in the cage of the extendedcurved tips during withdrawal. In this case, for example, thepathologist may request that at the end of the procedure, the entiredevice be placed into a sterile container for delivery to the pathologylab, where it may be digitally photographed to record the directcorrelation before the target excised is released from the device andanalyzed. These locating wires, according to embodiments, may also beused to immobilize a target during the procedure, especially if thetarget has a tendency to try to displace itself during the operation,and to aid in keeping a target in contact with curved tips 5 duringwithdrawal. FIG. 4 m shows yet another new type of locating wire andtip, according to another embodiment. This tip, which may be veryprecisely matched to the inside diameter of a central tube 7 of FIG. 5and other figures, may be used as a ramrod to deliver materials, such asmarkers, directly to a target site, may also assist in the delivery ofother liquids and semi-liquids, such as anesthetics or other medicationsor transplantable materials, and finally may also be used as a verysimple vacuum device, to replace or augment another vacuum system todraw materials, including but not limited to liquids and cells, from thesite before withdrawal of the device from the body.

These materials may then be emptied into a sterile container to enablelater histopathology or any other type of analysis post-procedure, orsimply delivered (to a pathologist, for example) with the rest of thedevice in a sterile container, as appropriate. Other uses of thelocating wire shown in FIG. 4 m, according to embodiments include togently release the tissue or foreign body obtained from the tip of thedevice upon complete retraction of curved tips 5 of the device (similarto a ramrod inserted into a central tube 7 from the proximal end), forrelease of a material delivered to the site by the device, for useintra-operatively to clear a central tube 7 of any blockage, for use inassisting parting-off, if necessary, of the proximal end of a tissue orforeign body to be isolated or excised if the edges of a flat plate tipare sharpened as well, and even as a localized energy (such as RF)diffusion source. Special locating wires that may be supplied with thedevice may be graduated along their length, which may enable theoperator to directly read the distance from the distal end of a centraltube of known length to a target, if the tip of a locating wire wasplaced into or in known and measured proximity to a target, as verifiedby image guidance or other techniques. According to one embodiment, thelocating wire may also not be an actual wire at all, but a fiber opticcable or electron beam apparatus, with a diffusing tip, or a tube whichmay be shaped as necessary—round pointed, flat disc, inverted funnel,mirror-ended or any other shape. Other shapes, configurations andapparatus are possible.

FIG. 5 shows several side views of the device 1, according to oneembodiment. As shown, a non- or differentially rotating central tube 7(not necessarily to scale) may be coupled to a tube chamber 3 with itsrod element 2 in various phases of deployment. In this illustration, anactuating disk 4, similar in function to that shown in FIG. 1 above, maybe centered on central tube 7, and to which may be attached the proximalbase of rod element 2. Axial movement of such an actuating disk 4,independently of any rotation of central tube 7, coupled with rotationof such a disk around central tube 7 results in a twisting motion on rodelement 2 which, in turn, orients curved tip 5 approximately 180 degreesfrom its original pointing position at rest within tube chamber 3 by theend of its travel. Such a central tube 7 may also be capable of slidingaxially with relation to tube chamber 3, and may be located in its owncentral sleeve. The tip of central tube 7 may thus be advanced axiallytoward a target independently of tube chamber 3 and either inconjunction with curved tip 5 of rod element 2 or independently of itsmotion.

The actuating disk 4 may be suitably configured to accomplish its statedpurpose. For instance, instead of using a twisting motion on rod element2 around central tube 7 to impart a curved, optimally 180 degreerotational movement to curved tip 5, according to one embodiment,actuating disk 4 may in fact be composed of a ring gear with a planetarygear driven by it and to which may be attached the proximal end of rodelement 2 (the sun in this instance being represented by a central tube7, which may also be surrounded by its own gear driving mechanism). Thetwisting movement of actuating disk 4 is significant, since it is bothsimple in conception, robust (few moving parts), easier to construct atvery small scale, and has the advantage that once twisted, rod element 2will tend to resist additional twisting, already being under torquetension in that state. This pre-loaded tension in torque, once achievedby the end of the lateral or axial travel of rod element 2, would tendto stiffen its curved tip 5, readying it for the next phase ofrevolutionary slicing with its edges to carve out the spheroid-shapedvolume within the soft tissue. This pre-tensioning may tend to keep theedges of curved tip 5 in their plane and prevent them from twistingunder side loads of cutting action, allowing them to always presenttheir sharp edges or RF energy to the tissue path to be described, whichwould result in the least deviation from their intended path and avoidunnecessary collateral tissue damage in proximity to a target tissue orforeign body.

A significant goal is to accurately correlate tissue diagnosis withimaging diagnosis. In order to successfully accomplish this, it iscrucial to know that the retrieved tissue actually and accuratelyrepresents the imaged abnormality. As illustrated, a central tube, withits other attachments in system, may be advanced laterally toward oraway from a target tissue or foreign body over an optionally-usedlocating wire 8 (or to deliver a locating wire 8), which may have beenplaced into, near, or through a target 6 pre- or intra-procedurally, thelatter case implying deployment of a locating wire 8 from central tube 7upon arrival of the device in proximity to a target, for such uses asdistance measuring to a target or for positive and accurate sighting ofa target with or without image guidance. The central tube 7 may also beused to move materials and other apparatus to and from a target site.Again, this figure illustrates the functionality of this device to allowplacement of curved tip 5 in spatial relationship to a target tissue orforeign body 6, in preparation for revolution of the edges of curved tip5 around such a target, without the curved tip 5 ever having disturbedthe target 6 in its location within the surrounding tissue. Theillustrations are not to scale.

Clinically and procedurally, the ability of a biopsy instrument toadvance gently towards a target provides several advantages, not theleast of which is avoidance of unnecessary tissue sectioning with theattendant damage to blood vessels, nerves and other organic structures.The ability of a biopsy instrument to advance gently towards a targetalso hastens recovery time for the patient, and reduces complications,due to the shorter length of the procedure (as compared, for example, tothe length of open surgical biopsy procedures). A related benefitconferred by embodiments is to enable the device to not only advancegently towards a target, but also to gently and precisely deploy itsworking surfaces in proximity to the target.

Embodiments provide the operator with methods, mechanisms and functionsto gently approach a target tissue or foreign body, deliberately deploycurved tips of penetrating rod elements around a target (thesemi-automatic mode of the device being discussed below), and only then,if desired, and only then make the final decision to carve out the threedimensional spheroid shape of the surrounding soft tissue, within whichthe target tissue or one or more foreign bodies are immobilized andisolated, surrounded with clean margins of healthy tissue. This abilityto position the device in relation to a target, still having minimallyinvaded the tissue that is penetrated, coupled with the ability tore-position if necessary in relation to the target, again with minimaldisruption to surrounding tissue, and then the ability to complete theprocedure when conditions are as perfect as possible gives inherentconfidence in the device, its functionality, and in the approach to theprocedure and the procedure itself on the part of the operator. Further,the device may be configured to function in single insertion, singleretrieval single insertion, single isolation or single insertion,multiple isolation modes, resulting in minimally invasive proceduresacross all such modes of operation.

FIG. 6 shows the distal end of the device 1 according to one embodiment,from an end-on perspective. FIG. 6 shows one embodiment of the device 1comprising six tube chambers 3, each of which contains a rod element 2,arranged around a central tube 7, which may be configured to be free tomove proximally or distally with relation to surrounding tube chambers,all of which may be enclosed in an outer tube/barrel 9. As also shown,central tube 7 may be advanced over a locating wire 8, or a locatingwire 8 or other elements may be advanced through its core. The device,according to one embodiment, may comprise a central tube 7 running fromits distal tip to its proximal extremity. In this manner, the proximalend of the central tube 7 may serve as a pathway through which fluids,cells, other materials, or contaminating materials may exit apercutaneous entry point of the device. Such structure enables controlof fluids, cells and loose tissue (among other materials) from a targetsite and to capture and contain such materials for analysis (or otherdesired procedures), as well as to allow the delivery,intra-procedurally, of medications, anesthetizing agents, markers orother biologically-active materials or apparatus to a target site orresultant cavity via the device. In their pre-deployment or loadedposition, the tips of curved tips 5 of rod elements may be oriented suchthat they point radially out from the center of the assembly.

Other configurations, such as embodiments in which the tips of rods areinitially oriented inward are possible, with additional rotation and/orrevolution then being necessary to bring the tips together over a targettissue or foreign body at the end of their paths. In this latterconfiguration, the tips of curved tips 5 may be machined (for instance,to a leaf shape) to completely close the ends of tube chambers 3 whichare normally but not necessarily cut at an angle at their extremitieslike hypodermic needles. Finally, this embodiment builds on theembodiments shown and described relative to FIG. 5, but with theaddition of a greater number of tube chambers 3 located around centraltube 7, which may be located in its own sleeve. In fact, any number ofsuch tube chambers may be placed around a central tube, in order toprovide as complete coverage of the final basket shape (similar to thelines encircling a basketball) of the curved tips around a target aspossible or desired, given the constraints of initial device tipcross-sectional limitations, physical characteristics of the elements ofthe device. Although a single tube chamber 3 may be contiguous tocentral tube 7, other embodiments provide for at least two tube chambers3.

According to other embodiments, the device may not comprise a centraltube 7, but may instead comprise a tube chamber 3 with a rod element 2.According to one embodiment, the tube chambers may be round incross-section to avoid any conflict with rod elements and curved tips asthey rotate, although they need not be round in cross-section. Otherembodiments provide for pie-shaped or polygonal cross-section tubechambers, and such embodiments may serve to reduce the overall diameterof an outer tube. Additionally, the tube chambers may simply be boredthrough a single outer tube/barrel 9, which may also be made of aninsulating material and additionally act as the sleeve of central tube7. One embodiment does not comprise a central tube 7 at all, but onlytwo or more tube chambers bored through a single outer tube/barrel 9, orcontained within an outer tube/barrel 9. Contained within each tubechamber 3 may be a rod element 2 showing its curved tip 5 with the tipsof those rod elements pointing radially outward from tube chamber 3 intheir loaded, at-rest configuration. According to other embodiments, thetips may also be pointing towards the central tube 7 in loaded, at-restconfiguration.

FIGS. 7A-7D illustrate different side views of the distal end of oneembodiment in various modes of operation. FIG. 7A shows one entryconfiguration of an outer tube/barrel 9, in this instance with its ownsharpened edge, rotating as a unit and approaching a target tissue orforeign body from inside of a previously placed locating tube 10, withthe tips of tube chambers 3 oriented around a central tube 7 in a sharp,tissue penetration orientation. Since in this illustration it isadvancing to a target site inside a locating tube that was pre-placed toprovide a clear path to a target, an outer tube may not have to rotateat all to penetrate to a target site. FIG. 7B shows the distal end of anembodiment, penetrating tissue in rotation as a unit en route to atarget site, this time over a locating wire 8, with the tips of tubechambers 3 optionally oriented around a central tube 7 and inside anouter tube 9 in a coring-type configuration for entering tissue in apathway to a target that may not have been previously been utilized(i.e., not following a prior coring biopsy procedure's pathway to thetarget). The tips of tube chambers 3, if individual tubes within theouter tube, may be angled with relation to an outer tube 9 to presentcutting teeth to facilitate coring penetration movement or such as topresent a minimum tip cross-section with a sharpened tip clusterarrangement, such as the configuration of FIG. 7A. Alternatively, such aconfiguration may be molded or machined into the tip of such an outertube/barrel with integral bored tube chambers. The tips of tube chambersand a central tube may also be configured to be flush with the leadingedge of an outer tube/barrel in a different penetration mode. In theembodiments shown in both FIGS. 7A and 7B, curved tips 5 of rod elementsare oriented radially outward from the tube chambers 3, although otherorientations are possible, prior to beginning any distalpenetration/rotation of their own once a target site is reached inproximity and straight ahead distally.

FIG. 7C illustrates the distal end of one embodiment, having arrived inposition close to a target 6, and having advanced over locating wire 8,which in this instance has been placed through target 6, in the earlystage of deploying curved tips 5 of rod elements 2. Here, it is assumedthat an outer tube 9 may have already begun rotation in sympathy withthat of rod elements 2 within tube chambers 3 in order to provide theaxial penetration/simple rotation/complex revolution coordinatedmovement for each of a curved tip's optimal path. FIG. 7D shows theterminal phase of the action begun in FIG. 7C, with curved tips 5 inposition around a target 6, and joined under the tip of a locating wire8, in preparation for rotation of the entire distal end of the device asa locked unit, which would part-off and isolate a sphere-like shape ofsoft tissue enclosing a target 6, with such action being a distinctphase (semi-automatic mode of the device) or simple continuation of theaction of the device distal tip (automatic mode of the device—frominitial tip deployment to full deployment and rotation of the deployedcurved tip basket for parting-off a target completely) from FIG. 7C. Asalso shown in FIG. 7D, a central tube 7, which may have graduation marksalong its length, similar to graduations on the outer tube, has beenadvanced towards a target 6 during the procedure, an optional actionthat may, for instance, serve to assist immobilization of a target (formany reasons, including immobilizing or fixing a target as it is removedfrom the body) or to apply vacuum to the target to be parted-off, or forother reasons, such as distance measuring between the tip of a centraltube 7 and the tip of a graduated locating wire 8, which can be readdirectly by the operator at the proximal end of the whole device,according to embodiments, or simply to establish the intended proximalboundary (a locating wire tip serving as the datum of the distalboundary, if used) of the clean margin of healthy tissue that isintended to enclose the target in the captured spheroid shape, accordingto one embodiments. This latter feature may also assist in positioningthe distal end of the device in the absence of or in supplement to otherimage guidance systems used during the procedure, and in any case alsomay serve as a positive indication that an excised target tissue orforeign body corresponds to what was imaged and defined as the target,which is an indication of great assistance to a pathologist analyzingthe captured and excised target and of great reassurance to theoperator, post-operatively. Finally, a central tube may even be movedforward to penetrate a target for material or apparatus deliverydirectly to a target, or to further immobilize it, or for delivery ofmaterials to a cavity left by excision of tissue post-procedurally, forexample, if it is decided to withdraw the device and leave the centraltube in place. Both a locating wire and a central tube may bepre-positioned, and a device according to an embodiment may be advancedto the target site over both of these elements.

FIG. 8 shows an external view of one potential design for one embodimentof a device 1. The device, in such an embodiment, may be configured tocomprise two major subsystems: a lower receiver/power/control unit 11and a separate upper carriage/gear/tip unit 12, which may be changedintra-procedurally for another upper unit with different tip dimensionsand/or configurations and, therefore, functionality, depending on thesize of a target tissue or foreign body desired to be extracted, forsubsequent cavity shaping and treatments, or other reasons such astherapeutic agent delivery or marker delivery, among others. Thisfeature also adds inherent safety to the device. For example, if thereis power or motor or control switch failure in the lower unit, thefailed lower unit 11 may be swapped out for a replacement lower unit 11during the operation, which can then continue to completion. Theembodiment of the device 1 of FIG. 8 may comprise, as shown, an outertube/barrel assembly 9, which encloses tube chambers 3 positioned aroundcentral tube 7, with the tip of a locating wire 8 optionally loaded intoa tip inside central tube 7 and exiting from the proximal (rear) end ofthe device from central tube 7, which may extend all the way through thedevice. According to embodiments, controls may be disposed on the devicefor ambidextrous use, and provision may be made for attachment of thedevice to stereotactic tables for flexibility in ensuing operations.According to one embodiment, the upper proximal end of the device may bemade of or comprise transparent material(s), thereby allowing for anoperator to directly visualize the movement of the inner mechanism ofthe device (above the curved line towards the rear of the device).

FIG. 9 shows a top view of the device illustrated in FIG. 8. Accordingto one embodiment, the central tube 7 may extend through the device fromdistal tip to proximal exit point and may be the only element of thedesign to do so, assuming that an optional locating wire is not alsoloaded, thus serving to isolate a target at the target site, to preventreleasing fluids or materials from the site to minimize potentialcontamination, and to provide a vacuum-tight pathway and port throughthe device to a target site and resultant in-situ cavity. Also shown inthis view are stereotactic table couplings 13.

FIG. 10 is an external side view of a variation of a design of device 1,according to one embodiment. The embodiment of FIG. 10 may comprise, ascontrasted with the embodiment of FIG. 8, an arrangement for a lowerpower/control unit 11 under a replaceable/interchangeable upper unit 12,showing an outer tube/barrel assembly 9, an optional carriage slidelever extension 48, and a longitudinally displaceable central tube 7 ofthe barrel assembly with an optional locating wire 8 shown loaded into acentral tube. The upper unit 12 may be manufactured by molding it oftransparent material which would allow the operator to directlyvisualize the mechanical action of the carriage and transfer case, asdiscussed below. Such a feature may allow for an even greater level ofcomfort on the operator's part that the device is functioning asdesigned, since the tip of the device will not otherwise be visible,except under image guidance, during the operation procedure. Both theembodiment shown in FIG. 10 and the embodiment illustrated in FIG. 8 maybe configured to function as hand-held, tether-less devices. Attachmentssuch as RF energy connections, vacuum source connections, externalpower, liquid and solid delivery systems, fiber optic cable placement toa target site, etc. that may be connected to a multi-connection port 25and an external power jack 26, shown in later figures, may provideadd-on functional enhancement as optional attachments. According toembodiments, the device, by itself, will accomplish the essentialoperations of penetration, surrounding, capturing, immobilizing,isolating, and removing a target tissue or foreign body from the body,in its tether-less form.

FIG. 11 shows additional elements of the device of FIG. 10, according toone embodiment, and illustrates various element details and externallayout of the ambidextrous operator controls and indicators. Thisembodiment provides for intuitive operations and controls. Thesestructures are described in clockwise sequence around the drawing,starting at the distal tip end, as follows: A locating wire 8 runningthrough the center of a center tube 7; a detachable and exchangeableupper mechanical/tip/carriage unit 12 of device 1; a gear lock button28; a central tube axial movement indicator 14, which acts as anexternal depth penetration indicator and scale; an outer tuberotation-only selector switch 50; a central tube vernier knob 24 foradvancement/retrograde action on the central tube for precisedisplacement distally or proximally of central tube 7 relative to outertube/barrel assembly 9; a multi-connection port 25 (for locating wire/RFpower/vacuum/fiber optic cable/delivery connections); a centraltube/locating wire locking mechanism 15, which may also be placed aftera separate port for vacuum running to a central tube (not shown); alocating wire 8; central tube 7; an upper unit locking lever 17;stereotactic table attachment or fixation points 13 (also located in twoother places for stable three-point fixation in this design); a lowerpower/control unit 11; a lower unit external power supply jack 26; anexternal power cord 27; a battery cover lock 29; a tube assemblyrotation switch 23; a curved tip retraction/rotation switch 22; a curvedtip advance/rotation switch 21 having a series of grooves cut into itsedge to allow the operator to distinguish it from a switch 22 by feelalone; an upper unit self-centering carriage slide lever 20; aforward/reverse tube assembly rotation selector switch 19; an RF powerswitch/indicator light 18; an upper unit hinge point tab 16; an outertube/barrel 9; and tube chambers 3.

Main controls and indicators functions, according to embodiments and asdescribed in FIG. 11 for the devices of FIGS. 8 and 10 may be asfollows: a curved tip advance/rotation switch 21 functions to extend andadvance, under rotation, curved tips 5 from outer tube/barrel assembly 9once the tip of the device has been correctly placed in proximity to atarget tissue or foreign body. Use of this switch also providessimultaneous, limited rotation of an outer tube/barrel in a ratio to theaction of rod elements forward/rotational movement for optimum enclosureof a target upon the end of the movement (curved tips 5 meeting on thedistal side of the target). At this point, the action may be stopped ifdesired, and the action is reversible at any time desired by withdrawingcurved tips 5 into their respective tube chambers 3 using a rod tipretraction/rotation switch 22 if the operator is not satisfied with thedevice's initial placement. Additionally, the action of tip deploymentfrom the distal end of the device may be controlled to happen veryslowly and precisely, if desired, as a switch 21 configured such thatfirst pressure will actuate a tip deployment/rotation/partial outer tuberotation at controlled speed (slow to fast with additional pressure) upto the first detent, which action will complete a tip deployment arounda target but not part it off.

When such a tip deployment is completed, actuation of a micro-switch 60(shown in FIG. 15) will stop further rotation of deployed curved tips.Taking pressure off such a switch at any time may serve two functions:to stop the action and to lock the device in its current position (forinstance, tips partially deployed). Once past a first detent, with tipsalready fully deployed around a target, additional pressure—a secondpressure—to a second detent will neutralize a micro-switch and cause anouter tube/barrel assembly to (or continue to) rotate, thus parting-offthe spheroid of target tissue from the surrounding tissue. Such a switch21, therefore, may be configured as a semi-automatic to automatic modeselector, since final rotational movement of the outer tube/barrelassembly for complete part-off of the target captured within the spherecreated by the movement of curved tips will not yet have occurred if afirst detent has not been passed (by definition semi-automatic mode).However, if the operator decides to press the switch past a first detentto a second detent at the very start of the procedure, the tips willfully deploy and the rotational parting-off of the target spheroid willfollow automatically in this modality. The fully automatic modality maybe used to great effect if the intent of the operator is to use the anembodiment of the present device as a single insertion-multipleisolation tool, and it is determined not to be necessary for the deviceto fully retrieve all of the isolated spheres of target tissues orforeign bodies thus created (the final one can be withdrawn at the endof the procedure if desired, of course), or when the operator isconfident of having good placement of the tip of the device in relationto a target.

The fully automatic mode may thus be used for those procedures wheretime is of the essence in removing a target, or in procedures in whichmultiple targets are chosen for isolation with a single percutaneousentry of the device distal tip. It may be extremely useful to be able torapidly isolate multiple targets, for instance with the use of RF energy(selected by, for example, an RF power switch/indicator light 18) tocurved rod tips during the procedure, to completely part-off thesetargets from surrounding tissue, and at the same time cauterize theoutsides of the spherical tissue specimens thus created whilesimultaneously cauterizing the inside of the cavities thus createdsurrounding the targets, which are simply left in situ, until furtherintervention. This isolation action may be all that is needed to treatcertain targets, since this process cuts off and denies a blood supplyto a target as well as controls bleeding at the site. The isolatedtarget(s) may then be removed or left in place to be removed by thebody's immune system. According to one embodiment, the central tube 7may also be extended into the target while it is still surrounded,immobilized and isolated by deployed curved tips of the device in theevent that the target is intended to be left behind in the body and notremoved, and would thus serve a purpose similar to a very preciselyplaced hypodermic needle to deliver an agent, such as an enzyme, virus,acid, marker dyes, lysing agents such as diazolidinyl urea or alcohol,or other special drug or material, including removable radioactivesources or nano-particle drug or cell delivery materials as well asimplanted materials that are targeted and delivered directly to a targetto further assist or speed up the healing and/or clearance of theisolated, at present sealed target in its spherical shape, surrounded byclean margins, and if desired, a cauterized outer shell. The centraltube 7, according to one embodiment, may also serve as a conduit for afiber optic cable to be advanced to penetrate an isolated target fordelivery of UV light, electron beam, LED light or diffused laser energy,similar to those techniques used in dermatology, or for an RF energy orheating and diffusing specially configured locating wire or otherlocalized tissue treatment mechanism. This may be the finalinterventional phase, if desired, for a specific target, and oncecompleted, tips of the device may be withdrawn into their respectivetube chambers, the central tube retracted, whereupon the operator maythen reposition the device to isolate another target while the device isstill in the body. If desired, the operator can complete the procedureby removing the final target from the body.

If the operator continues to hold such an extension/rotation switch 21in the fully on (at a second detent) position at the end of parting-offa target in either semiautomatic or automatic mode, the outertube/barrel 9, along with the captured target in curved tips basketshape, may be configured to continue to rotate, allowing for easywithdrawal of the whole device tip from the body under rotation, usingto advantage the principle of compound friction overcoming simplefriction (i.e., it is easier to twist out a dowel from a tight hole thanto try to just pull it straight out). According to one embodiment, thecurved tip retraction/rotation switch 22, which may also be a rheostatfor varying speed but with only a single detent, may be configured towithdraw the curved tips with the same degree of outer tube/barrelassembly 9 synchronized rotation as was used for tip penetrationdescribed above. This minimizes tissue damage proximal to a target site,since the tips of curved tips 5 follow a predictable penetration andretraction pathway, which is primarily characterized by a penetrationrather than slicing motion, and any needed repositioning or re-aimingmay be accomplished without excess damage to tissues surrounding atarget site. The ratio of curved tip penetration or retraction underrotation to outer tube/barrel rotation may be dependent on differenttissue matrices, and may be matched to the present device for each tipdiameter that will be used (assuming for example that tips from FIG. 4 aare standard tips for the device, which may thus be selected based onthe size of the sphere to be created around different sized targets).Such a retraction/rotation switch 23 may be configured to have two otherauxiliary functions. The first such auxiliary function may be tocounter-rotate an outer tube/barrel assembly when entering the body froma percutaneous opening, for example, and in penetrating the whole tip ofthe device under this counter rotation towards a target site. A secondauxiliary function of such a switch 23 may be to release an obtainedtissue sphere from the curved tips of the device safely into a sterilecontainer for transfer to the pathologist or other laboratory personnel,post-operatively, or to release a material to the target site,intra-operatively or post-operatively.

The outer tube/barrel assembly rotation switch 23, if comprised in suchan embodiment, may, when engaged, cause simple higher speed/lower torque(than that of the action of switches 21 and 22) rotation of the outertube/barrel in either direction, without affecting curved tipdeployment, which may be used if desired for percutaneous tissuepenetration to a target site (forward rotation, selected by aforward/reverse selector switch 19) with rod elements remaining in theirindividual tube chambers or for withdrawal of the device from the bodyupon completion of the desired phases of the whole procedure (reverserotation, selected by a forward/reverse selector switch 19), or during afollow on procedure such as perfecting the cavity after removal of atarget tissue or foreign body as preparation for subsequent procedures.This switch may be configured to be activated by an outer tuberotation-only selector switch 50. A gear lock switch 28 may be providedas a safety feature to positively lock the fully deployed curved tips inthat position, regardless of rotation of any other element of thedevice. This may help ensure that a captured target would not be lostduring withdrawal from the body. As is discussed hereunder, there may beno need to lock the gears when curved tips are not deployed and reverserotation is selected by such a switch. An RF energy selectorswitch/indicator 18 may be used to turn on RF power current to switches21 and 22, and also to indicate that the power is on using, for example,an LED light on a switch 18. According to one embodiment the RF powermay only be applied to curved tips for penetration/parting-off wheneither such a switch 21 or 22 is in use. A central tube vernier knob 24and its position indicator 14 may be used by the operator to advance orretract a central tube axially within the device and in relation to atarget, and to precisely note its position relative to other elements ofthe device (such as the very tip of the device).

A central tube/locating wire locking mechanism 15 may be used to lockthose two elements together, which may be useful if, for instance, thetip of a locating wire is on the distal side of the target, and the tipof a central tube is on the proximal side of the target, with a distancebetween those two points equal to the distal and proximal poles of thesphere that will be carved out by the known fully deployed diameter of acurved tip basket. If so placed, the operator may be assured that atarget will be fully captured in the ensuing phases of the operation.Finally, a carriage slide lever 20 operates a linkage 47 (shown in FIG.14) that may be configured to move, axially forward or backward, theentire outer tube/barrel unit without affecting the placement of thedevice outside of the body. This feature's mechanical function isdescribed hereunder relative to FIG. 15. Accordingly, if the entireouter tube/barrel assembly is moved axially during the deployment ofcurved tips by action of a switch 21, the resulting three dimensionalshape of the tissue that will be captured and eventually parted-off willbe modified from a spherical shape to either a slightly elongated sphere(ovoid shape) or a flattened sphere on the distal side. Thisintra-procedural shape alteration fine-tuning feature may be useful tothe operator in ensuring that additional clean margin tissue will becaptured on the distal side of the target (carriage moves forwardtowards the end of a curved tip deployment phase), or equallyimportantly, for example, in flattening the sphere on the distal side (acarriage slides backwards at the end of the curved tip deploymentphase), to avoid getting too close to sensitive tissue or structures onthat side of the target, such as a chest wall, nerve, or major blood orlymphatic vessel. This ability to add another control to the final shapeof tissue that may be isolated and excised is also an added safetyfactor of the device, and may also be useful in capturing clean marginsof healthy tissue around an elongated target tissue, according to thepresent embodiments.

FIG. 12 illustrates a top view of the device of FIG. 10, according toone embodiment, showing the device 1, with the outer tube/barrelassembly 9, the central tube 7 passing completely through the device, areplaceable upper slide unit 12, and a handle/lower slide/power unitassembly 11. This figure also illustrates one exemplary layout of theambidextrous controls that may be viewed from this perspective,including a vernier adjustment knob 24, an upper slide lock 17, a depthindicator 14, as well as a lock mechanism 15, which may also serve as asealing mechanism for the end of the central tube 7 (with or without alocating wire or fiber optic cable passing through it to prevent releaseof fluids or other substances into the operating theater atmosphere),and a locating wire.

This view also shows a model designator area 65, where an upper slidehousing has a model number and tip size/shape molded into it orotherwise affixed for easy reference by the operator in selecting anupper unit pre-loaded with a certain size and curved tip shape, asdiscussed under FIG. 11. Model numbers may vary by tip size andconfiguration of a gear drive that is matched to different tips, as willbe discussed under FIG. 15. The model number of an upper unit would thuscorrespond to one of a listed series of upper unit models on a laminatedchart for reference, supplied with the device in one of its embodiments,and the chart may comprise all of the parameters that would beapplicable for each model number, including such information as totalcurved tip length when deployed, total central tube length forcorrelation to the graduations on the locating wires, the type oflocating wire supplied with the upper unit model, the curved tip shape,and other parameters. Such an upper unit may be intended to be molded ofa transparent (e.g., plastic) material so that the operator can actuallysee the movement of the internal mechanism, as desired.

FIG. 13 shows an upper unit hinge point tab 16, an upper unit lockinglever 17 of an upper unit, and a lower handle/power/control unit 11according to one embodiment. The ability to change out,intra-operatively if necessary, either an upper or lower unit(s) of thedevice illustrates a significant safety factor that may be built intothis device. If there is failure of any part of a lower unit, it may bereplaced and a replacement unit attached to an upper unit to allow theprocedure to continue. If it is determined that curved tips 5 maximumdiameter would be insufficient to completely enclose a target tissue orforeign body with clean margins all around it, the entire upper unit maybe exchanged for one with pre-loaded rod elements and curved tips of agreater dimension (or vice versa for a smaller dimension, as the casemay be), with several upper units available to the operator forselection during the procedure. Alternatively, the operator may haveseveral of the devices 1 at hand, each loaded with tips of differentdimensions or configurations, to be used as desired for differenttargets during the same procedure. Such a lower unit may be configured,as shown in FIG. 14, so that the only mechanical connection between anupper unit 12 and a lower unit 11 is the top of a motor/pinion assembly31, which engages an upper unit gear drive automatically when an upperunit is locked down to a lower unit, and a sliding carriage link 47(both of which are not shown in this illustration).

This ability to change out either a complete upper unit or a completelower unit also illustrates that a lower unit, at the least, may bere-usable, since no part of its structure actually enters the patientduring the procedure, and as will be shown, in FIG. 15, the outertube/barrel 9 and associated parts of the complete tip of the device maybe readily and easily changed for a complete replacement unit as asub-component assembly within the structure of the upper unit 11 of thedevice. This built in design feature allows for maximum flexibility anddevice cost effectiveness, as approximately 90% of the device may beconfigured to be re-useable from procedure to procedure, and 100% of thedevice may be configured to be recyclable at the end of its useful life.A lower unit 11, with a defect which may be limited, for instance, to amalfunctioning or worn out switch, may be returned for refurbishmentwith a replacement unit provided to the operator for use in themeantime. The refurbished unit may then be sterilized, packaged andready for re-issuance for thousands of future operations, until itsuseful life had passed, at which time it may be disassembled and itsparts recycled. A similar scenario may be envisioned for all of thesubassemblies of the upper unit 12.

FIG. 14 is a side view of the device of FIG. 10, according to oneembodiment, showing internal placement of a motor/pinion gear assembly31, a battery power source 30, a lower unit external power supply jack26, a transfer case 46 containing a drive mechanism that automaticallyengages and connects to a pinion gear of a motor/pinion assembly 31 whenan upper unit 12 is dropped onto and locked to a lower unit 11, theinternal placement of a self-centering sliding carriage 32, and acarriage slide link 47 engaging a sliding carriage 32 and a carriageslide lever 20. The battery source may be a readily available 9-voltrechargeable battery, which is useful for remote field operations, wherea supply of batteries and a recharging station would answer all of thepower needs for the device, in a simple embodiment, although other powersources may be envisioned, as may be an external power source. The motormay be a commercially available direct current unit, used for manypurposes such as in model cars. These motors have sufficient torque forthis purpose, are inexpensive, and eliminate the need for reversinggears in a simple instrument, since reversing current flow to the motorreverses its direction, such as controlled by switches 21 and 22 of thedevice shown in the embodiments shown in FIGS. 8 and 10. Also shown is abattery compartment cover lock 29. Details of the internal mechanisms ofa sliding carriage 32 and a transfer case 46 may be found in FIGS. 15and 16, respectively. This figure also illustrates the simplicity ofreplacing a motor/pinion gear assembly with, for instance, a purelymechanical drive unit, such as a wind-up motor, in place of a DC currentmotor shown in this figure. Associated controls in such an embodiment ofthe device would in that case be limited to the essential mechanicallinkages (such as a collar brake to start and stop a motor and aseparate reverse idler gear to compensate for a one-way rotation of aspring powered motor) to a purely mechanical motor/pinion gear assembly31, which would be rod tip extension/rotation switch 21 and rod tipretraction/rotation switch 22, and in that case the device would stillperform its basic functions (surround a target, capture it, immobilizeit, isolate it and retrieve it), as will become apparent with referenceto FIGS. 15 and 16.

FIG. 15 shows the working mechanical/electrical details of aself-centering sliding carriage subassembly 32, according to oneembodiment. First shown in FIG. 14 above. FIG. 15 shows theself-centering sliding carriage subassembly 32, configured to house aprincipal driving mechanism of a device tip subassembly, and to slideaxially on its side rails 39 in matching grooves of an upper unit 12housing. A self-centering mechanism of such a carriage housing may bebased on four springs 49 (of which only the lower left spring is shown)locating it to its normal position within an upper unit 12. The axialmovement of such a carriage on its slide rails may be controlled by acarriage slide lever 20, as shown in FIGS. 10 and 14, and a connectingcarriage slide link 47, as shown in FIG. 14, engaging a carriage leverpivot sockets 40 in the base of a carriage housing, as shown in thisfigure. A carriage, according to one embodiment may contain most of themechanical drive elements, and such a carriage and its containedelements may be configured to carry out all of the intended motions thatwould affect the movement of curved tips, an outer tube/barrel assemblyand the actions for target tissue or foreign body isolation/part-off andexcision. Each of the elements contained within such a sliding carriagehousing may be configured to be dropped in with locking snap-on tabs orplates holding them in their intended positions, which may be located bycolumns or pylons molded into the carriage housing, for ease of assemblyand manufacturing, as well as replacement as discussed further below. Acarriage may be replaced in an upper unit 12 as a whole subassembly orjust a device tip subassembly, contained within a carriage subassemblyas discussed below, may be replaced between procedures. This may limitthe need for replacement and sterilization of the entire device betweenprocedures, and any number of replacement sterilized subassemblies(carriage or device tip, preferentially the latter only) may be usedwith the same upper unit 12 and lower unit 11 of the device.

The driving components located within such a carriage housing maycomprise an outer tube/barrel assembly 9 proximal end press fit into anouter tube collar/gear 33, and through which pass rod elements 2 (out ofthe proximal ends of their tube chambers, which are press fit into holesin an outer tube collar gear 33) and a central tube 7, which emergesfrom its sleeve that ends at a gear 33 like tube chambers. The collar ofthis element may be configured as a thrust bearing within its housing,as shown, and may positively lock the device tip to a carriage 32, andthus to an upper unit 12. When such a carriage 32 moves axially forwardor backward, it moves the tip of the device as well, which may serve tofine tune the movement of deployment of curved tips from their tubechambers, thus altering the three dimensional shape of a target to beisolated and/or excised, as discussed relative to FIG. 11 above. Thisfigure illustrates the very simple and robust manner in which a carriagemay accomplish this action, in conjunction with a slide lever 20 andlinkage 47. If such a slide lever 20 of FIG. 11 is locked all the way inits extreme forward position, the carriage slide link 47 (shown in FIG.14) will engage through a carriage lever pivot socket into a depressionin an upper unit (carriage lock 61, shown in FIG. 15), thus locking acarriage 32 rigidly within an upper unit 12. Additional locking pointsmay be provided between a carriage and an upper unit housing to enablethe operator to lock such a carriage at its forward-most, middle andafter-most positions by a second external button lock 63, shownhereunder relative to FIG. 18.

In this configuration, rod elements 2 may extend through holes in anouter tube collar/gear 33 and may be positively anchored at theirproximal ends to and through a rod element clutch gear 35, with theirproximal tips extending through that element to contact an RF energydistributor contact plate/wiring/housing subassembly 41. The RF energydistributor contact plate may be kept in contact with the proximal endsof rod elements 2 by springs within that subassembly housing, which doesnot rotate, as shown in this figure. The RF energy distributor contactplate is also shown in FIG. 15A in the lower right hand corner of theillustration, showing that its contact face may be segmented as well,with one segment for each rod element 2 contained in the device tip(outer tube/barrel 9 subassembly), represented by the dots in eachsegment, as though rotation has been frozen for an instant forillustration purposes. Power to all segments may be provided byattaching a wire to the outside continuous conducting circumference of acontact plate delivering power to all segments, as shown. As theproximal tips of rod elements 2 pass over an RF energy distributionplate, the contact allows the RF energy to pass to curved tips of rodelements, if selected by a switch 18 of FIG. 11, and if either of thecontrol switches 21 or 22 is actuated. If an RF distributor contactplate is segmented as shown, with insulated lines between segments onits face, the RF energy, which may be of the pulsed type, the rodelements will be additionally pulsed as they pass over each segment inrotation. This pulsing action may assist the RF energy's action byinitializing and maintaining the arc of energy between rod element tipsand the tissue encountered in their path.

The following elements of a carriage subassembly list for illustrationpurposes the important elements of one embodiment of the device of FIG.8 or 10. This discussion of one embodiment assumes that a motor/pinionassembly is connected to a sliding driveshaft 52 via its own worm gearpinion/driving gear (as shown in FIG. 16) on a driveshaft 52; aself-centering sliding carriage 32 with its associated parts (elements40, 61, 39 and 49) as the housing for this minimized subassembly, anouter tube collar/gear 33, an outer tube gear sleeve 42, a tensionspring 37 whose principle function is to balance the exit forces of thecurved tips from their tube chambers and to assist gear 35 to induce thecurved tips of the rods to re-enter their tube chambers when retractedby giving an extra force to a clutch gear 35 as it returns axially in aproximal direction. It is anticipated that the curved tips, because oftheir spring-like nature, may tend to want to exit their respective tubechambers of their own volition once they have been initially extendedforward as a result of the action of gear 35, and once that starts, gear35 may be in a position of having to hold the rod elements back asopposed to having to push them forward. A tension spring 37 may beprovided to balance that tendency and to also serve as an additionalretrograde assist to gear 35 as it travels axially back to itsrearward-most position and drags the curved tips back into their tubechambers.

Also comprised in this embodiment for the subassembly within a carriageare a rod element gear casing 36, a rod element clutch gear 35, amicro-switch 60, a radiofrequency (RF) energy contact plate/housing 41,a rod element pinion gear 38, and a sliding driveshaft 52. Theseelements work together to provide the desired action on the outertube/barrel assembly 9 and rod elements 2. The direct drive to a rodelement clutch gear provides low speed/high torque to that gear, sinceit is anticipated that torque requirements may be a significant limitingfactor. In this configuration, the outer tube pinion gear 34, itssliding driveshaft 51, and gear lock 28 may each be unnecessary, and maybe considered optional. By eliminating gear 34 as outlined above, anentire transfer case, as shown in FIGS. 14 and 16, may be minimized oreliminated as well, as is discussed below.

Examining the principles of movement of the outer tube collar/gear 33 inrelation to the rod element clutch gear 35 yields the following. Asshown in FIG. 15, the two gears are shown in exploded view and have notbeen assembled, for ease of analysis of their functions. The actualassembled configuration for rod element clutch gear 35 may be over acentral tube of outer tube collar/gear 33, with the grooves of the shaftof rod element clutch gear 35 engaging the two pinion dowels shownapproximately midway on the shaft of the collar/gear 33. According toone embodiment, these two pinion dowels may take the form of ridgesmolded into and spiraling around the shaft of a tube collar/gearassembly to match the pitch and ride in the grooves of a rod elementclutch gear 35. This embodiment may effectively prevent stress shearingof the two pinion dowels, as a great deal of torque loading may bepresent at these two points, and would also provide a long-wearing andvery robust structure. One limiting factor for these spiral ridges mayinclude the friction load that they will bear as they ride in thegrooves of a clutch gear 35, but as this mechanism may be configured forlow speed/high torque, it is assumed that either a surface treatment orlubrication be carried out. The rod element proximal ends may beembedded through the base of a rod element clutch gear 35, according toone embodiment, and may thus be in contact with an RF energy contactplate 41, whose wiring may be connected to a plug socket or slidingcontact plate an the rear bulkhead of a sliding carriage 32 housing.Such a rod element gear casing 36 may be configured to slide over anouter tube gear sleeve 42, and a tension spring 37 may be configured tosurround a rod element gear casing.

When rotational force is applied to a sliding driveshaft 52 from themotor, it will turn rod element gear pinion 38, which will turn rodelement clutch gear 35. As this happens, the torque will be applied tothe grooves of that gear to the pinion dowels (or spiral ridges) on theshaft of an outer tube/collar gear 33. As a result, the rod elementclutch gear will begin to rotate around the shaft of an outertube/collar gear and advance laterally forward, twisting itself and therod elements, which are also moving forward with a clutch gear, aroundthat shaft, in a motion similar to that explained in FIG. 5, and infact, clutch gear 35 takes the place of rod actuator element 4 of FIGS.1 and 5. As the rod elements are twisted (they must twist since gears 33and 35 would not be rotating with the same speed) and moved axiallyforward (to the left in the illustration), this action is transmitted tothe distal extremity of the rod elements, causing curved tips 5 toextend, deploy and rotate around a target (this action is not shownhere, but illustrated in FIGS. 1 and 5). As the rod element clutch gearis driven by a pinion gear 38, it slides forward along that pinion gear.As it receives the rotational force from that pinion gear, it also actson the pinion dowels of an outer tube collar/gear 33, and that gear inturn starts to rotate the entire outer tube as the rod elementsthemselves are twisted around its axis. The ratio of outer tube rotationto rod element axial deployment/twisting rotation may be a function ofthe angle of the groove of a rod element clutch gear 35 engaging thepinion dowels of an outer tube collar/gear 33 as well as the resistanceof rod elements to twisting and frictional forces acting on an outertube/barrel. The torque imparted to an outer tube may be increased ifthe grooves of the rod element clutch gear are steeper, or more nearlyparallel to the central axis of that portion of a clutch gear. If thegrooves are of shallower pitch (i.e., closer to perpendicularity to thecentral axis of a clutch gear), less relative torque may be applied toan outer tube collar/gear. The actual degree of the pitch of the slotsin a rod element clutch gear may thus determine how much an outertube/barrel assembly will rotate as the rod elements are pushed axiallyand rotate on their axes by twisting around the shaft of a rod elementclutch gear 35. This ratio may be fine-tuned at will.

Another significant ratio is that of axial travel of a clutch gear 35toward gear 33, and the total amount of rotation that wrapping rodelements around its shaft will be. A simple way of visualizing thesignificance of this ratio is that the total distance traveled axiallyforward by a clutch gear 35 must end with rod elements being twisted sothat they rotate on their axes enough to bring their curved rod tips toat least 180 degrees from the direction that they were initiallypointing in their tube chambers, but not much more than that, if any.This action, as previously discussed, would allow the tips to travel outand around a target tissue or foreign body. In actual fact, curved rodtips may not have to travel a full 180 degrees, and may also travel over180 degrees, if desired, according to embodiments. The nominal targetfor rotation while penetrating forward for the rod tips may be, forexample, approximately 185 degrees (to compensate for twisting dragforces on deployed rotation or to allow the tips to cross over eachother at the distal ends, if they are of the configuration shown in FIG.7A), although other targets for rotation may be found to provide utilitywithin the present context. The total length of travel of such a clutchgear 35 in forward travel (which is primarily determined by the totallength of the matched curved tip of a rod element selected), the pitchof its grooves, the total friction load of the mechanism, the torquedelivered to a clutch gear, the tension spring resistance, an outer tubefrictional resistance to rotation, the density of the tissue expected tobe encountered by the curved tips in deploying (tippenetration/revolution), combined rod element flexibility, and otherfactors may be taken into account in fine tuning the operation thissubassembly, as those of skill in this art may recognize. For instance,the grooved shaft of gears 35 and the ridged shaft of gear 33 may bevery long with a very shallow twist, to allow rod elements plenty oflength to twist/rotate around a clutch gear 35 shaft at full forwardlock. The longer that distance is, the easier it will be to twist therods and the easier it will be to assemble the device duringmanufacture.

The outer tube/barrel assembly may not necessarily be round incross-section, and may have ridges, spirals or other surface treatmentto assist in frictional drag or to lessen it. The shafts of penetratingrods may be of “X” or spiral cross-section along their shafts, forexample, or thinner in the area expected to be twisted, or have othercross-section that allows twist, but resists angular deflection whenloaded axially, or have varying cross-sections along its length. In anycase, the use of this gear arrangement described herein, is rugged, easyto assemble, inexpensive, and most importantly, assures that thefunctional motions described herein—those of simultaneous rod tip axialpenetration, deployment, rotation and revolution out and around a targettissue or foreign body with clean margins around it—may be carried out.When a rod element clutch gear has reached the end of its forwardtravel, its gear casing 36 may come into direct contact with an outertube collar/gear 33 over its outer tube gear sleeve 42, compressing atension spring 37 as it approaches gear 33. Once it is in directcontact, it can go no further forward. (the curved tips 5 of the deviceare now at their fully deployed stage around a target, are pre-loadedwith torque, and cannot rotate further) and from that point all of thedriving torque applied to a clutch gear 35 may be transmitted directlyto an outer tube collar/gear 33, driving it in rotation in the directionof its own rotation. At that point, it also trips a micro-switch 60,which cuts off power to the first detent of a switch 21 of FIG. 11, asdiscussed under FIG. 11. If that switch 21 is pressed to its seconddetent, a micro-switch 60 may be disabled, allowing a clutch gear 35 tocontinue driving a gear 33 until the switch 21 is released. In thislatter mode (switch 21 pressed all the way to its second detent), gear35 will drive gear 33, an outer tube/barrel assembly 9 will rotate, anda target enclosed by the fully deployed curved tips will be parted-offfrom the surrounding tissue as the edges of the curved tips carve thespheroid shape enclosing a target.

If a retraction/rotation switch 22 of FIG. 11 is activated, it drivesrod element gear pinion 38 in reverse. A micro-switch 60 would not beconnected to switch 22, so it may be actuated at any time, for instancein alternation with switch 21 as the operator is positioning the devicein proximity to a target and making short, incompletepenetration/retraction movement of the curved tips to optimally placethe device, and perhaps verify that placement with image guidancedevices, before continuing the procedure. If such a rod element clutchgear is in its rear-most position (rod tips not deployed out of theirtube chambers around a central tube), such a rod element clutch gear 33may be configured to drive an outer tube collar/gear 33 in reverserotation, since it will be impossible for gear 35 to move any farther tothe rear, and all of its torque moment is transmitted to gear 33 throughthe pinion dowels on its shaft. This reverse rotation of an outertube/barrel assembly may be used as a standard device penetration fromthe percutaneous entry point to final position to a target. The rotationof an outer tube/barrel assembly 9 en route to a target site has alreadybeen discussed relative to FIGS. 7A-7D above. Such rotation may assistpenetration using the principle of compound friction overcoming simplefriction. With reverse rotation, the rod elements curved tips areprevented from accidentally deploying, since a clutch gear is driving inreverse and actually locking the rod tips in their respective tubechambers. Retraction/rotation switch 22 of FIG. 11 and other figures mayalso be used to retract rod element curved tips back into their tubechambers, if a rod element clutch gear 35 is already at its forward-mostposition, locked up against a tube collar/gear 33. This switch wouldalso be the one to use if the curved tips have been deployed orpartially deployed by action of a switch 21, and it is desired toretract the tips for repositioning of the device, or for release of thecollected target after the procedure is finished, either in singleinsertion-single retrieval, single insertion-single isolation or singleinsertion-multiple isolation mode of the device, according to oneembodiment.

Also shown in FIG. 15 are a separate higher speed/lower torque optionalouter tube pinion gear 34, a driving gear 33, and its associated slidingdriveshaft 51, which may act in concert with gears 38, 35 and 33 at thesame time, or separately from gears 38 and 35, according to oneembodiment. Control elements 19, 23 and 50 of FIG. 12 may be dedicatedto this outer tube pinion gear's action in concert with the gearing of atransfer case discussed and illustrated in FIG. 16. An alternative usefor pinion gear 34 with a shortened driveshaft 51 may be to include withthis subassembly a tension drag collar 66 and external control knob, inwhich case the driveshaft would not necessarily be driven. This tensionadjustment mechanism may be configured to increase drag on gear 33 inrelation to the relative movement of gear 35, and may limit gear 35'stendency to impart too much rotation on gear 33 during forwarddeployment of the rod elements, and may be controlled by the operatorvia an external knob. It is anticipated that this fine tuning drag ortension feature may find particular utility with low density tissue suchas fatty tissue encountered by the tips of the device, which may tend toupset the balance of the relative action of gears 33 and 35, since therewould be less external friction drag on an outer tube/barrel assemblyand less resistance to penetration of curved tips through such lowdensity tissue, and thus tend to increase the rotational factor of anouter tube/barrel assembly and gear 33 with relation to the movement ofgear 35. A simple gear lock mechanism 28 may be used when a clutch gear35 is in its foremost position against gear 33. This may be configuredas an optional safety feature to ensure that these two gears do nottwist themselves away from each other when the curved tips are fullydeployed around a captured target and thus accidentally let go of thetarget during extraction. In actual fact, use of this safety feature isa redundant mechanism, since a worm drive pinion for gear 35 (shown in atransfer case of FIG. 16), coupled with a worm gear—like quality of agear 35's slotted shaft acting on the pinion dowels of a gear 33effectively lock gears 33 and 35 together in whatever position relativeto each other that they are driven to by one single gear—the rod elementpinion gear 38. This keeps the rod elements from untwisting and tryingto drive gear 35 in reverse, and contributes to the torque loadingexperienced by each rod element in its fully deployed state which, inturn, makes its curved tip edges more rigid in plane and increasescurved tip side cutting efficiency.

Finally, although it is shown located at the rear of upper unit 12 ofFIG. 11, the details of a central tube vernier knob 24, a central tubepinion gear 44 and a central tube rack gear 43 are shown towards theright of a carriage. A turning knob 24 may be configured to act on arack and pinion mechanism to move central tube 7 in relation to thedevice, allowing the tip of central tube 7 to advance to or into andretract from a target, and if locked to a locating wire 8 by a centraltube/locating wire lock 15 of FIG. 11, a vernier knob 24 will advance orretract both central tube 7 and locating wire 8, relative to the device.This latter action may be taken, for instance, if the operator wishes toremove the device and a target from the body with both a locating wireand a central tube in exactly the position they were relative to thetarget just before removal of the target from the body, which also aidsin immobilizing the target during extraction. A knob 24 also may beconfigured to actuate the external depth indicator 14 on the outside ofan upper unit 11, as shown in FIG. 11. It should be noted that thecentral tube may run through all of the main driving elements (gears 33,35, tension spring 42 and RF energy assembly 41, a transfer case of FIG.16, and other elements) and may not be affected by any relative motionsof any of these elements.

In this FIG. 15, the following elements within a sliding carriagesubassembly 32 may be easily replaced, according to one embodiment,without replacing any other parts of an upper unit 12 or lower unit 11;an outer tube/barrel assembly 9 (with rod elements 2 and tube chambers3, and a central tube 7) and a subassembly comprised of gear 33 withattached sleeve 42, tension spring 37, gear 35 with attached casing 36,and RF energy contact plate/housing 41. This essentially constitutes theentire forward tip of the device, and this ability to change just theseelements as a matched subassembly allows for several key advantagesrelated to this embodiment. Such advantages may include, for example,the ability of an operator to change out the entire tip of the devicefor another tip with different curved tip dimensions or characteristics,cost effectiveness of the whole device because approximately 90% of thewhole device is reusable, environmental friendliness because 100% of thedevice is recyclable, and so on. As noted above, the length of axialtravel (and therefore the lengths of their shafts) of gears 33 and 35relative to each other may be matched to the set of rod elements thatthey drive, especially as related to the curved tip length of those rodelements. According to one embodiment, when gears 33 and 35 are at theirclosest proximity to each other and locked into that position (gear 35all the way forward against gear 33), the curved tips of the rodelements should be fully extended and rotated (fully deployed). Whengears 33 and 35 are as far from each other as possible (gear 35 fullyretracted), the very tips of the curved tips of the rod elements shouldbe fully retracted into their individual tube chambers, in loaded orat-rest position. This is why it may be desirable to be able to changedevice tips as a subassembly to attack different sized target tissues orforeign bodies in the body. The sliding carriage housing may allow forthese components as a subassembly to be dropped in place and lockeddown, making change out of this device tip subassembly relativelysimple.

It can also be envisioned, by one skilled in the art, that otherarrangements or designs for a device tip main driving subassembly arepossible, such as belt drives, sun/planetary gears/ring gears or othergear arrangements, perpendicular tabs from a rod element shaft to acentral spiral groove that rotates them on their own axes as they areadvanced axially, and other operating mechanisms and controls. Suchalternative designs should be considered to be within the scope of theembodiments shown and described herein.

FIG. 16 shows a top down view of a transfer case 46 in one embodiment,located within upper unit 12 of the device in this embodiment and lockedto it by locating tabs 59, containing various drive gears and clutchmechanisms, configured to transfer rotational movement from amotor/pinion assembly 31 to the sliding driveshaft(s) 52 and/or 51, andthus to the sliding carriage mechanism of FIG. 15, all of which arelocated to allow central tube 7 to pass axially through this drivingmechanism unencumbered by a drive mechanism. Placement of this transfercase within upper unit 12 is outlined in FIG. 14, and thethree-dimensional shape of that transfer case outline is replicated inthis illustration for ease of understanding. This subassembly within anupper unit 12 may be configured such that it may be dropped down onto amotor/pinion assembly and engaged through pinion aperture 55 with idlergear 54, in the device outlined in FIGS. 8 and 10, and as shown in FIG.13, according to one embodiment. The idler gear 54 may be configured toengage a transfer gear assembly 53, which may be configured to engage acommon drive/gear selector assembly 56 with its sliding driveshaft 57and sliding selector gear unit 62. A sliding selector gear 62 may beactuated by an outer tube rotation-only selector switch 50. An outertube rotation-only switch 50 was shown on the device in FIGS. 8 and 10,and its action as a lever to selector gear 62 on the sliding driveshaft57 is shown by the double headed arrow next to switch 50 on this figure.

This embodiment shows the ability of selector gear 62 to act as an idlergear between sliding driveshaft elements 51 and 51, which extend forwardto the sliding carriage of FIG. 15. In this configuration, selector gear62 chooses either to drive both driveshaft elements simultaneously(meaning that rotational power is sent to both gears 33 and 35 in asliding carriage subassembly of FIG. 15) or only driveshaft 52, whichpowers gear 35 of sliding carriage subassembly of FIG. 15 through wormgear 58 in this transfer case subassembly. As discussed relative to FIG.15, this worm gear 58 acts as a pinion gear, along with the slottedshaft of gear 35 acting on the shaft of gear 33, effectively lock gears33 and 35 together in whatever relative axial position they are to eachother when rotational power is interrupted (motor shut off). This actioninterrupts and freezes the position of the curved tips 5 of rod elements2 relative to the mouth of their tube chambers 3 at any time theoperator desires by releasing switches 21 or 22, as outlined previously.Other embodiments of a transfer case in which only one or the other ofdriveshafts 51 and 52 is powered may be devised if such functionality isdesired. As noted relative to FIG. 18 below, all or most of thistransfer case may be eliminated or minimized in an embodiment, andfurther, many different configurations that would comprise the use ofbelt drives and pulleys or other arrangements may be envisioned asmechanical equivalents to that shown and described herein, which are tobe considered to fall within the scope of the present embodiments.

FIG. 17 shows three side views of an upper unit and device tip,according to one embodiment, in three stages of exiting a target sitewhile withdrawing a captured and excised target in a fully deployed tipbasket. The vertical line represents an exemplary percutaneous entrypoint and the device in the top view shows a simple fabric sleeve or bag45, which may be attached to the device tip at its forward end by eithera circle clip, an “O” ring in a groove on an outer tube/barrel 9, orother means, such as adhesive. As the device is withdrawn, preferablywith simultaneous rotation in either direction of an outer tube/barrelas shown, with its captured target, a sleeve/bag element 45 will tend tofold over and wrap itself around the captured target in the formed tipbasket as it turns itself inside out, which may thus accomplish threeimportant functions, among others:

-   -   (1) to decrease friction between a captured target and the        tissue through which it must pass on its way out of a        percutaneous incision;    -   (2) to give an even more positive grip of the curved tips on a        captured target, and    -   (3) to prevent contamination of the healthy tissue on the        extraction path to a percutaneous incision point.

The sleeve/bag element 45 may be constructed of a variety ofcommercially available material, such as nylon weave, Tyvek®, M5®, ahigh modulus thin film, a non-woven material or other material thatresists tearing and is ultra-thin and flexible. It is not necessary thatthe sleeve/bag element 45 be resistant to heat from, e.g., an RF energysource, since its normal position intra-procedure is along the shaft ofan outer tube/barrel 9. If the device is used in any of its singleinsertion-single isolation, single insertion-single isolation or singleinsertion-multiple isolation modes, a sleeve/bag element 45 may bepresent or omitted, as desired by the operator. The sleeve/bag element45 may be given a variety of interior/exterior surface treatments toeither reduce friction (inside surface which when deployed becomes theouter surface) or to increase it (outside surface which becomes insidesurface when deployed, and thus grips the captured target, the sleevebag/element 45 may also have special forms, features or devicesincorporated into it to elute a number of drugs, anesthetics or otherbiologically active substances to the traversed tissue, either on theway to a target site or upon leaving it. A sleeve/bag element 45 mayalso be attached to a locating tube 10, as shown in FIG. 7A, throughwhich the device 1 is inserted to approach the target tissue site, andgiven simultaneous withdrawal of the locating tube 10 and the device 1,the sleeve/bag element would deploy around the target tissue asdescribed above and below. This latter procedure would allow formultiple replacement locating tubes with attached sleeve/bag elements tobe used with a single device 1 intra-procedurally.

FIG. 18 shows a device 1, according to one embodiment, with essentialcontrols and features in a simplified form. In this embodiment, thecontrols have been limited to an RF power switch/indicator light 18, acarriage slide lever 20, a penetration/rotation switch 21, theretraction/rotation switch 22 and a central tube vernier knob 24. Alsoshown are an optional carriage lock button 63 and an external carriageposition indicator 64. According to this embodiment, a motor/pinionassembly 31 may occupy the space of a transfer case 31 (as shown inFIGS. 14 and 16), and the pinion of a motor/pinion assembly may be aworm gear drive, as opposed to a bevel gear shown in FIG. 14, with adirect link to sliding driveshaft 52 to drive a rod element gear pinion38, as shown in FIG. 15. As described relative to FIGS. 15 and 16, theuse of a worm gear pinion for the drive mechanism of a slidingdriveshaft 52 may obviate the need for a gear lock mechanism 28 of FIG.15, since a gear driven by a worm gear cannot itself normally drive aworm gear. FIG. 18 also shows an outer tube/barrel assembly 9 which alsoshows the curved tips 5 fully deployed around tissue containing atarget. In this illustration, it may be assumed that the finalrotation/part-off has occurred, and that an outer tube/barrel assemblywill be rotated, as the device is withdrawn from the body. As thisoccurs, either with or without rotation of the outer tube/barrelassembly, an outer tube capture sleeve/bag 45 may be configured tounfold as shown in FIG. 17, wrap itself around a curved tip formedbasket and the captured target may be removed from the body for deliveryto the pathologist in a sterile container. Finally, as describedrelative to FIG. 4, locating wires that may be supplied with this devicemay feature graduation marks along their length, thus enabling theoperator to read the exact distance between the tip of the locating wireand the tip of a central tube directly off the proximal end of a centraltube. The operator may also deduct the distance between the tip of acentral tube and the tip of the device (tips of the tube chambers) fromreading the carriage position indicator 64 and a central tube positionindicator 14. This information may be of vital importance in correlatinga target obtained with the pre-procedure target observed.

According to embodiments, various components, such as an outertube/barrel assembly (device tip), that will briefly be placed intoliving tissues may be formed of or comprise biocompatible materials suchas stainless steel or other biocompatible alloys, or may be made of orcoated with polymers and/or biopolymeric materials, or any othermaterial combination as needed to optimize function(s). For example,penetration/cutting elements may be made of or formed by hardened alloysor carbon composite and may be additionally coated with slipperymaterials to optimize passage through living tissues of a variety ofconsistencies and frictions. Some of the components may bedifferentially surface-treated with respect to adjacent components. Asleeve/bag system may be made of or comprise multiple types of material,since it is not exposed to the RF-generated heat and serves its purposeonce such RF use has ceased, if used at all, according to oneembodiment. The various gears may be made of or comprise any suitable,typically commercially available materials such as nylons, polymers suchas moldable plastics and others. If used, a motor powering the variouspowered functions may comprise of a typical, commercially availableelectric DC motor, such as are commonly found in other medical devices.The handle (lower unit) and upper unit of the device may likewise bemade of inexpensive, moldable plastic or other suitable rigid, easilyhand held material and the handle may be configured in such a way as tomake it easily adaptable to one of any number of existing guidingplatforms such as stereotactic table stages. The materials used in thedevice may also be carefully selected from a ferro-magnetic standpointsuch that the instrument may be compatible with magnetic resonanceimaging equipment, which are commonly used for biopsy procedures. Thevacuum/delivery assembly components may comprise commercially availablesyringes and tubing, for connecting to the instrument's commonconnection port, along with easily available reed valves for switchingbetween suction and emptying materials such as fluids, which may besuctioned by the vacuum components. The materials collected by theinstrument in this manner may then be ejected into an additionalexternal, yet portable liquid storage vessel connected to the tubing ofthe instrument for discarding or for safe keeping for analysis andtesting. The relative or absolute sizes of the individual componentsdescribed herein may be matched to the intended use of the device.Therefore, no implication of relative or absolute sizes for anycomponent or for the device in its embodiments should be inferred fromthe depictions or descriptions herein.

The power source may be an external commercially available transformerto DC current, approved for medical device use, and plugged into aprovided socket in the device, or may be an enclosed battery of anysuitable voltage/current that is readily available commercially. Thebattery may be of one time use and recyclable or may be of therechargeable variety. The power source may, according to one embodiment,comprise a wind-up spring-driven motor or in a very simplifiedembodiment, be entirely manually driven, with appropriate minimalchanges to the device to accommodate such a power source.

Advantageously, embodiments are minimally invasive both externally(entry into the body through a percutaneous procedure) and internally.Indeed, the operator has the ability to reposition the tip bywithdrawing the penetration elements within their delivery tubes andredeploying from another angle or position, with resulting minimalsurrounding tissue damage since the points of the penetration elementsfollow a predictable curve and are not slicing or parting-off tissueuntil subsequent stages. Only when the operator is satisfied as to theamount of tissue that will be captured by final deployment and spatialplacement of the penetration elements, for example to obtain cleanermargins on one or more sides of the target tissue, or for clearance inrelation to surrounding sensitive structures, such as a chest wall, isit necessary to make the final decision to pursue subsequent stages,such as final part-off capture, collection and retrieval of the sampletissue, which may be forestalled temporarily or indefinitely in order tochange the tip of the device to allow a larger or smaller target sample,for example. Also, according to embodiments, the forward cutting tips ofthe penetration rods may be used, without alteration of their naturalshape, attachment or any other modification, to penetrate the tissuesegments on approach to the target, and then may be used to surround,immobilize and isolate the tissue specimen. Thereafter, the samepenetration rod tips may be used to part-off the specimen at the end ofthe isolation stage, as well as to augment retrieval of the collectedspecimen. Having these multiple functions saves valuable cross-sectionalarea, which in turn, creates a device that is as minimal as possible inouter diameter for entry and penetration to the target site whileproviding a means to capture and remove a target tissue much larger thanthat outer diameter. This is clinically significant, since embodimentsoptimize the ratio so that the clinician and patient can have the bestof both worlds.

The manner in which the curved tips deploy around the target tissue isalso advantageous. Indeed, the curved tips are configured to deployaround the target tissue without touching the suspect lesion that it issurrounding. In this manner, the clinically significant tissuearchitecture of the collected specimen is least likely to be disrupted.Again, it has been clearly demonstrated that minimizing tissue artifactand preserving tissue architecture as much as possible leads to a betterdiagnosis and more favorable postoperative results. The sliding carriageelement advantageously provides structure within an upper unit of thedevice for locating the various internal drive components. Moreover, theability to move this carriage with its components as a unit gives theoperator unique options to vary the captured tissue sample length andvolume in real time, intra-procedurally, with a simple mechanicalarrangement powered manually or automatically as selected.

Also advantageous are the multiplicity of entry/forward penetration andwithdrawal mechanisms; a post-procedural cavity shaping capability, bothwith the carriage function as well as manually; the ability to approacha target tissue or foreign body head on; the ability to extract maximumvolume for a minimum surface area (spherical shape of captured tissue);the ability to bypass structures on the way to a target or avoidstructures proximal to a target site; the ability to pre-select thevolume of tissue to be excised; the ability to deliver a multiplicity ofmaterials and apparatus to a target site and even within the target whenit is immobilized or isolated; the ability to conduct the procedure withimage guidance or without it, if necessary; the multiplicity ofadditional functions and features that may be added to the basic device;the simple, robust, scalable and recyclable structure of the deviceitself; the safety factors associated with the replaceable upper andlower units of the device; and the ability to change only the device tipbetween interventional procedures.

Finally, embodiments are highly portable, requiring minimal supportingequipment, especially in battery or mechanical embodiment such as in awind-up spring powered alternative (not shown) or simple manualoperation. Advantageously, embodiments may find widespread applicationthroughout the world for excision biopsy procedures. Other instrumentsdesigned for the purpose of tissue biopsy need, by their designlimitations, far more adjunct supporting mechanisms, such as externaldrive systems, fluid management and tissue management systems, as wellas separate retrieval-assist systems, all of which are built in oroptional features of the present embodiments, but which are not requiredfor operation.

Variations are possible. For example, according to one embodiment, thepenetrating rod element(s) that are housed in their loaded deliverytube(s) need not be pointed or have cutting edges to accomplish such apurpose, but may in fact be distally fan-shaped, barbed, webbed or haveanother configuration configured for isolation or capture of a specifictarget. The number of penetrating rod elements may vary considerablyfrom one to any number desired for efficiency in capture, isolation andretrieval of a target. Embodiments of the present device may also becurved rather than straight along its longitudinal axis and may still beconfigured to function properly.

According to one embodiment, a biopsy/excision/isolation device maycomprise a multi-tube multiple finger or rod capture and collectcomponent for example, rendering the device potentially suitable to manycommercial/industrial applications where handling a variety orsingle-type material(s) is/are desirable, potentially on a much largerscale than needed in medical biopsy procedures. For example, oneembodiment may be adapted for use on a robotic arm for collection andretrieval of samples, whether solid or semi-solid, in remote ordangerous locations. Moreover, due to the lightweight nature ofembodiments, it may replace existing capture mechanisms where weight isextremely important, such as for remote planetary rovers. Also,according to one embodiment, the forward distal tip and/or body of thedevice may be configured to be steerable without loss of any of itsfunctions, which may have uses both within the medical field as well asoutside it. Additionally, the length of the barrel assembly portion ofsuch a device may be configured to have most any length, with varyingdegrees of flexibility, and in a variety of shapes that may find utilityin remote applications.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of the embodiments. Indeed, the novel methods, devices and systemsdescribed herein may be embodied in a variety of other forms.Furthermore, various omissions, substitutions and changes in the form ofthe methods and systems described herein may be made without departingfrom the spirit of the embodiments. The accompanying claims and theirequivalents are intended to cover such forms or modifications as wouldfall within the scope and spirit of the disclosed embodiments. Forexample, those skilled in the art will appreciate that in variousembodiments, the actual structures may differ from those shown in thefigures. Depending on the embodiment, certain of the steps described inthe example above may be removed, others may be added. Also, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure. Although thepresent disclosure provides certain preferred embodiments andapplications, other embodiments that are apparent to those of ordinaryskill in the art, including embodiments which do not provide all of thefeatures and advantages set forth herein, are also within the scope ofthis disclosure. Accordingly, the scope of the present disclosure isintended to be defined only by reference to the appended claims.

1-13. (canceled)
 14. A device, comprising: a tube, the tube defining aproximal end and a distal end configured for insertion into tissue; arod element disposed within the tube, comprising a curved and unattachedfree end portion that is biased against an internal surface within thedevice to assume a first radius of curvature; wherein the rod element isconfigured for deployment from the distal end of the device, the curvedand unattached free end portion of the rod element being configured toassume a second radius of curvature when deployed outside of the distalend of the device, the second radius of curvature being smaller than thefirst radius of curvature; and wherein the curved and unattached endportion of the deployed rod element is configured to delimit a volumeand/or to capture a portion of tissue within the volume.
 15. The deviceof claim 14, wherein the rod element is configured to rotate.
 16. Thedevice of claim 15, wherein the curved and unattached free end portionof the rod element is configured to describe a spiral path whiledeploying from the distal end of the device.
 17. The device of claim 14,further comprising a separate tube chamber for the rod element andwherein the device is further configured to impose a distally-directedmovement on the rod element within the tube chamber.
 18. The device ofclaim 14, further comprising a locating wire within the tube, thelocating wire being configured to be advanced from the distal end of thedevice to a desired target region within the tissue.
 19. The device ofclaim 14, further comprising a central tube being configured to beplaced into, advanced or retracted from the distal end of the device toa desired target region within the tissue, and through which may beadvanced at least one of a locating wire and materials to be provided tothe target tissue, the central tube being further configured to carry avacuum for withdrawal of materials from the target region.
 20. Thedevice of claim 14, further comprising a locating tube within which thedistal end of the device may be advanced to the desired target regionwithin the tissue.
 21. The device of claim 14, wherein the curved andunattached free end portion of the deployed rod element is configured tobe retracted along with the device while maintaining the volumedelimited by the curved and unattached free end portion of the deployedrod element.
 22. The device of claim 14, wherein the curved andunattached end portion of the deployed rod element is configured to beretracted into the distal end of the device after having circumscribedand parted-off a volume of tissue.
 23. The device of claim 14, furthercomprising a sleeve that is configured to deploy over the volumedelimited by the curved and unattached end portion of the deployed rodelement.
 24. The device of claim 23, wherein the sleeve is configured toturn itself inside out to thereby envelop the volume formed by thecurved and unattached free end portion of the deployed rod element. 25.The device of claim 14, comprising a plurality of rod elements disposedwithin the tube, the curved and unattached free end portion of eachbeing biased against a respective internal surface within the device toassume the first radius of curvature; wherein each of the plurality ofrod elements is configured for deployment from the distal end of thedevice, the curved and unattached free end portion of each of theplurality of rod elements being configured to assume the second radiusof curvature when deployed outside of the distal end of the device; andwherein the curved and unattached end portions of the plurality ofdeployed rod elements are configured to collectively delimit a volumeand/or to capture a portion of tissue within the volume.